Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-24 @ 6:47 PM
NCT ID:
NCT01286857
Eligibility Criteria:
Inclusion Criteria:
1. Chronic wounds (venous, pressure or diabetic type), and acute wounds suitable for NPWT therapy according to the investigator's judgment
2. 1cm2 ≤ wound size ≤ 200cm2
3. Male or female, 18 years and above
4. Signed Informed Consent Form
5. Subject understands the written Patient Information
Exclusion Criteria:
1. Need for frequent dressing changes, i.e.\<48 hours between the changes
2. Critical ischemia (for wound healing) according to investigator's judgement
3. Malignancy in the wound and/or wound margin
4. Target ulcer previous not successfully treated with NPWT within 48 hours
5. Poorly controlled diabetes according to investigators judgement.
6. Osteomyelitis which has been left untreated
7. Infection which has been left untreated
8. High risk for bleeding complications
9. Exposed blood vessels, organs or nerves
10. Current or within 3 months treatment with chemotherapy or irradiation
11. Known hypersensitivity to the dressing material
12. Expected technically impossible to seal the film to achieve a vacuum treatment
13. Expected non compliance with the Clinical Investigation Plan (CIP)
14. Pregnancy
15. Subjects not suitable for the investigation according to the investigator's judgement
16. Subjects previously included in this investigation
17. Subjects included in other ongoing clinical investigation at present or during the past 30 days
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01286857
Study Brief:
Protocol Section:
NCT01286857